Pentacam AXL 70100Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K152311); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Aug 8, 2023Open, Classified

   Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

   Z-2483-2023 · Root cause: Process control · Recall details · FDA record ↗

2. Jul 8, 2022Open, Classified

   Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

   Z-1673-2022 · Root cause: Software design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152311. One submission often covers many models, so check the product and lot details in each record.

• Z-0635-2018 · Nov 21, 2017 · Terminated
  OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam A